36700 Federal Register / Vol. 63, No. 129 /Tuesday, July 7, 1998 / Notices

The goal of Team Biologics is to ensure

the quality and safety of biological

products and quickly resolve

inconsistencies and bring products into

compliance. It is designed to promote

uniformity between CBER and the field

and among FDA field components

associated with inspections, policy

implementation, and current good

manufacturing practice interpretation.

In April 1998, the responsibility for

inspecting manufacturers of licensed in

vitro diagnostics was transferred to

Team Biologics investigators. The

purpose of this workshop is to provide

an overview of the Team Biologics

concept to this segment of regulated

industry, share the agency’s experience

with Team Biologics’ inspections of

manufacturers of licensed in vitro

diagnostics to date, and provide

manufacturers with an overview of

FDA’s expectations under this program.

The agenda and any other relevant

information will be available

electronically via the Internet at ‘‘http:/

/www.fda.gov/cber/scireg.htm’’.

Transcripts: Transcripts of the

workshop may be requested in writing

from the Freedom of Information Office

(HFI–35), Food and Drug

Administration, rm. 12A–16, 5600

Fishers Lane, Rockville, MD 20857,

approximately 15 working days after the

workshop at a cost of 10 cents per page.

FDA will videotape the workshop and

copies of the tapes will also be made

available through the Freedom of

Information Office.

Dated: June 20, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–17878 Filed 7–6–98; 8:45 am]

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DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[FDA 225–96–6000]

Memorandum of Understanding

Between the Food and Drug

Administration and the Defense

Alliance for Advanced Medical

Terminology

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is providing

notice of a memorandum of

understanding (MOU) between FDA and

the Defense Alliance for Advanced

Medical Terminology (DAAMT). The

purpose of the MOU is to enable

government agencies to exchange

information and jointly pursue research

endeavors related to medical device

safety and effectiveness.

DATES: The agreement became effective

October 17, 1996.

FOR FURTHER INFORMATION CONTACT:

Thomas B. Shope, Center for Devices

and Radiological Health (HFZ–140),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–443–3314, ext. 32.

SUPPLEMENTARY INFORMATION: In

accordance with 21 CFR 20.108(c),

which states that all written agreements

and memoranda of understanding

between FDA and others shall be

published in the Federal Register, the

agency is publishing notice of an MOU.

Dated: June 26, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

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[FR Doc. 98–17859 Filed 7–6–98; 8:45 am]

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